A Self-management Based Survivorship Intervention for Chinese Cancer Survivors
- Conditions
- Physical Symptom DistressNeoplasmsWeight Management
- Interventions
- Behavioral: First stage control interventionBehavioral: Cancer survivorship care interventionBehavioral: Step-up targeted personalized interventionBehavioral: Second stage control intervention
- Registration Number
- NCT05534386
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.
- Detailed Description
This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 486
- Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
- have completed primary and adjuvant treatment within the past six months
- Patients diagnosed with metastatic cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description First stage intervention: Control intervention First stage control intervention Patients randomized to the control group will be given a set of pamphlets explaining symptoms and describing skill-based self-management for symptom management and lifestyle recommendations. Each pamphlet addresses one of the 7 most commonly-reported symptoms (sleep difficulties, fatigue, neuropathy, pain, anxiety, depression, and fear of cancer recurrence) observed in Hong Kong cancer survivors, plus two on lifestyle recommendations (physical activity and healthy diet). All pamphlets are developed based on the self-management framework. First stage intervention: Cancer survivorship care intervention (CSCI) Cancer survivorship care intervention Patients randomized to the CSCI will attend a 120-minutes survivorship clinic in which each participant will be assessed by members a multidisciplinary team comprising a registered nurse, a dietitian, an exercise physiologist and a psychologist/counsellor. During the visit, participants will receive a personalized (1) treatment summary, (2) assessment and recommendation on managing physical and psychological symptoms, (3) assessment and recommendation on dietary advice, (4) assessment and recommendation on physical activity, and (5) advice on managing potential psychosocial issues. While this is a multidisciplinary clinic, the nurse will be the core facilitator who will give a summary of health assessment report including personalized healthy lifestyle advice and action plan to each participant at the end of the visit. Second stage intervention: Step-up targeted personalized intervention Step-up targeted personalized intervention The step-up targeted personalized intervention will adopt a multi-disciplinary approach but place more emphasis on coaching to enhance patient' skills to manage their symptom burden and weight control. Second stage intervention: Control intervention Second stage control intervention Patients randomized to the control arm at the re-assessment at 4-months post-baseline will continue in the trial as usual (i.e. those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlets).
- Primary Outcome Measures
Name Time Method Proportion of symptom distress caseness (distress prevalence) 4-months post-baseline The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =\>7 will be categorized as moderate-to-severe symptom distress cases.
Change in total score of health-related quality of life Baseline and 4-months post-baseline The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) will assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty.
Proportion of patients with suboptimal weight control 4-months post-baseline Anthropometric measures include weight, height, and body composition, which will be measured in light clothing and without shoes. Weight and body composition including body fat, total body water, muscle mass, bone mass and BMI will be measured using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). Height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.
- Secondary Outcome Measures
Name Time Method Proportion of symptom distress caseness (distress prevalence) 12-months post-baseline The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =\>7 will be categorized as moderate-to-severe symptom distress cases.
Change in total scores of self-efficacy Baseline, 4-months post-baseline, and 12 months post-baseline The process outcome is change in total scores of self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS) from baseline to 4-months post-baseline, and baseline to 12 months post-baseline. This is a 6-item scale assessing patients' confidence to perform six self-management behaviours. Each item is rated on a 10-point Likert scale. A high score indicates high self-efficacy.
Health state Baseline, 4-months post-baseline, and 12 months post-baseline Health questionnaire (EQ-5D-5L) including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression will be used to assessed participants' health state. Each dimension has 5 levels from no problems, slight problems, moderate problems, severe problems to extreme problems. The EQ-5D-5L also records participants self-rated health on a vertical visual analogue scale, where higher values indicate better health the participants can imagine.
Fear of cancer recurrence Baseline, 4-months post-baseline, and 12 months post-baseline The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.
Illness perception Baseline, 4-months post-baseline, and 12 months post-baseline Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).
Proportion of patients with suboptimal weight control 12-months post-baseline Anthropometric measures include weight, height, and body composition, which will be measured in light clothing and without shoes. Weight and body composition including body fat, total body water, muscle mass, bone mass and BMI will be measured using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). Height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.
Trial Locations
- Locations (7)
Kwong Wah Hospital-Breast Center
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Obstetrics & Gynaecology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital-Department of oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Prince of Wales Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Tung Wah Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong